FDA Inspection 1114262 — Anschel Technology Inc.

Anschel Technology Inc. — FEI 3010120146

The FDA completed an inspection of Anschel Technology Inc. on December 31, 2019 in Rocky Point, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 31, 2019
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: Devices
Location
Rocky Point, NY (United States)

Citations

IDCFRDescription
2142521 CFR 820.184(f)DHR - UDI not included
63021 CFR 803.17Lack of Written MDR Procedures